The American Foregut Society Formally Requests Medical Policy Coverage of EsoGuard® to Enhance Early Detection of Esophageal Cancer

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Aug 13, 2024, 08:16 ET

Request for insurance coverage aims to enhance early detection and treatment of esophageal precancer to prevent highly lethal esophageal cancer

NEW YORK, Aug. 13, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that the American Foregut Society (AFS), a leading society of gastroenterologists and surgeons collaborating to improve patient outcomes, including in esophageal disease, has formally requested that health insurance providers update their medical policies to include the EsoGuard^® Esophageal DNA test as a covered service.

The open letter, posted on the society website, highlights the critical need for early detection of esophageal precancer (Barrett's Esophagus or BE) to prevent highly lethal esophageal cancer, the strong scientific evidence supporting the use of EsoGuard as a minimally invasive screening alternative to endoscopy, and EsoGuard's incorporation in the practices of AFS physicians. The letter strongly advocates for medical policy coverage of EsoGuard consistent the most recent gastroenterology society guidelines and legislation in many states mandating coverage of biomarker tests like EsoGuard.

"We are confident that expanding access to the EsoGuard test will empower providers with an essential triage for upper endoscopy (EGD) that enables the early detection of BE," wrote Reginald Bell, M.D., FACS, the Chair of the AFS Board, on behalf the society. "The goal of early BE detection is to facilitate prompt treatment and surveillance, ultimately reducing the risk of cancer progression. By being available as a point-of-care test in primary care offices, EsoGuard directly reduces health disparities in endoscopy access, aligning with the mission of the American Foregut Society. We urge you to consider the immediate coverage of the EsoGuard test."

"The AFS is the preeminent society of renowned physicians and surgeons, focusing on esophageal cancer and other disease of the foregut. We are grateful that the society has used its platform to advocate on behalf of patients at risk for this highly lethal but preventable cancer," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "The AFS's vocal advocacy highlights the critical need for accessible and effective screening tools, such as EsoGuard, to detect esophageal precancer to prevent cancer. Its strong endorsement of medical policy coverage of EsoGuard will enable more patients to benefit from esophageal precancer testing. We are committed to working with all payors to ensure that at-risk patients have broad access to EsoGuard, a critical weapon in our fight to prevent this cancer."

About Lucid Diagnostics

Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard^® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck^® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.

For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.

Forward-Looking Statements

This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid's control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid's future operations, see Part I, Item 1A, "Risk Factors," in Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

SOURCE Lucid Diagnostics